EP2982402B1 - Injektionsnadelanordnung und medikamenteninjektionsvorrichtung - Google Patents

Injektionsnadelanordnung und medikamenteninjektionsvorrichtung Download PDF

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Publication number
EP2982402B1
EP2982402B1 EP13881154.2A EP13881154A EP2982402B1 EP 2982402 B1 EP2982402 B1 EP 2982402B1 EP 13881154 A EP13881154 A EP 13881154A EP 2982402 B1 EP2982402 B1 EP 2982402B1
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EP
European Patent Office
Prior art keywords
injection needle
discharge tube
drug
needle assembly
fitting
Prior art date
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Active
Application number
EP13881154.2A
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English (en)
French (fr)
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EP2982402A4 (de
EP2982402A1 (de
Inventor
Yoichiro Iwase
Takayuki Yokota
Hisao Yabe
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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Filing date
Publication date
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Publication of EP2982402A1 publication Critical patent/EP2982402A1/de
Publication of EP2982402A4 publication Critical patent/EP2982402A4/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3293—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion

Definitions

  • the present invention relates to an injection needle assembly used as fitted to a drug discharge tube of an injection syringe, and a drug injection device having the injection needle assembly.
  • the present invention relates to a device according to the preamble of claim 1, such as it is, e.g., known from US5964737 .
  • a syringe storing a drug for injection and an injection needle assembly having an injection needle are separately formed, and such drug injection devices are used to perform an injection, after the injection needle assembly is attached to the drug discharge tube at a tip of the syringe.
  • the injection needle assembly is generally attached to the drug discharge tube with taper fitting.
  • the drug discharge tube is formed to have a male taper shape (a shape of a circular truncated frustum of a cone) in which an outer diameter becomes continuously smaller toward a tip.
  • the injection needle assembly is provided with a fitting portion having a cylinder hole, and this fitting portion is formed to have a female taper shape (a hole with a shape of a circular truncated cone) in which an inner diameter becomes continuously smaller from an opening of the cylinder hole with a size corresponding to the drug discharge tube.
  • the male taper shape and the female taper shape are formed with the same taper ratio.
  • the taper ratio of the taper shape is expressed as fractions such as A/100 or as percentages such as A%, when a diameter decreases by A mm per 100 mm, for example.
  • ISO594-1 1986 (Title: Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements) and in ISO594-2: 1998 (Title: Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings).
  • ISO594-1 specifies a type of a connection with only a taper fitting
  • ISO594-2 specifies a type of a connection with a taper fitting with a lock mechanism using a screw.
  • Each standard presupposes that a taper ratio of a taper shape is 6/100.
  • Patent Literature 1 A drug injection device fixed with taper fitting is described in Patent Literature 1, for example. This drug injection device is fixed using taper fitting with a lock mechanism.
  • a syringe (cylindrical body) described in Patent Literature 1 has a drug discharge tube (discharge portion) with a male taper shape provided at a tip.
  • a screw portion serving as a lock mechanism is provided on an outer peripheral surface of the drug discharge tube at its base.
  • An injection needle assembly (needle hub) described in this Patent Literature has a cylinder hole having a female taper shape at a fitting portion.
  • a screw portion threadedly engaged with the screw portion of the drug discharge tube is formed on the inner peripheral surface of the fitting portion.
  • Patent Literature 1 JP 2011-212185 A
  • the drug discharge tube of the syringe is inserted into the fitting portion of the injection needle assembly, and the syringe and the injection needle assembly are relatively rotated to allow the screw portions to be threadedly engaged with each other to attach the injection needle assembly to the syringe.
  • the drug discharge tube is pushed into the fitting portion with the tightening action by the rotation, whereby they are taper-fitted to each other. By this fitting, a leakage of a drug can be prevented.
  • the injection needle assembly has to be pressed against the drug discharge tube (syringe) with a certain level of force in order to surely fix the fitting portion and the drug discharge tube to each other. If the pressing force is weak, the taper fitting is not established, so that a drug might leak.
  • the present invention is accomplished to solve the above problem, and aims to provide an injection needle assembly and a drug injection device that reduce force required for an attachment between the injection needle assembly and the drug discharge tube, and that can surely be attached even with weak force without causing a liquid leakage.
  • An injection needle assembly accomplished to attain the foregoing object includes : an inj ectionneedle; a fitting portion which is formed into a cylindrical shape and has one end serving as a fitting opening, the fitting portion having a female taper shape in which an inner diameter of a cylinder hole of the fitting portion becomes smaller toward the inner side from the fitting opening; and a hub provided with the fitting portion for holding the injection needle, the injection needle assembly being used in such a manner that the female taper shape of the fitting portion is fitted to a drug discharge tube, which has a male taper shape in which an outer diameter of a cylinder becomes smaller toward a tip, from the fitting opening, wherein when the male taper shape of the drug discharge tube has a taper ratio of N/100, the female taper shape of the fitting portion is formed to have a taper ratio of M/100, wherein M > N.
  • the fitting portion has a guide wall that is formed on an inner wall of the cylinder hole at the fitting opening by increasing the inner diameter of the cylinder hole.
  • the drug discharge tube has a lock mechanism provided with a screw portion, and the fitting portion has a screw portion threadedly engaged with the screw portion of the lock mechanism.
  • a drug injection device of the present invention includes : a syringe having the drug discharge tube; and the injection needle assembly according to claim 1.
  • the taper ratio of the female taper shape of the injection needle assembly is larger than the taper ratio of the male taper shape of the drug discharge tube.
  • the fitting portion has a guide wall formed on an inner wall of the cylinder hole at the fitting opening by increasing the inner diameter of the cylinder hole, an insertion opening is increased, whereby the drug discharge tube can easily be inserted into the injection needle assembly.
  • the injection needle assembly can be fixed to the drug discharge tube by surely pressing the injection needle assembly against the drug discharge tube. Therefore, a leakage of a drug can surely be prevented, and the holding force of the injection needle assembly attached to the drug discharge tube can be increased.
  • Fig. 1 is an exploded side view illustrating one embodiment of a drug injection device 1 of the present invention.
  • the drug injection device 1 is used for injecting a drug by puncturing a skin surface with a needle tip.
  • the drug injection device 1 for intradermal injection for injecting a drug into an upper layer of a skin is illustrated as one example .
  • the drug injection device 1 includes an injection needle assembly 2 of the present invention, and a syringe 3 to which the injection needle assembly 2 is detachably mounted.
  • a pusher for pushing a drug is inserted into the syringe 3.
  • Fig. 2 is a partially enlarged sectional view illustrating the drug injection device 1 illustrated in Fig. 1 .
  • Fig. 2 illustrates a tip part of the syringe 3.
  • the syringe 3 to which the injection needle assembly 2 is attached is a synthetic resin syringe used for a known drug injection device.
  • the syringe 3 is made into a cylinder, and the inside of the cylinder is defined as a drug storage unit 21 storing a drug.
  • a cylindrical drug discharge tube 22 communicating with the drug storage unit 21 is mounted at the tip of the syringe 3.
  • the drug discharge tube 22 has a male taper shape in which the outer diameter of the cylinder decreases toward the tip.
  • This taper shape is formed with a taper ratio of N/100.
  • N is a positive number.
  • a flat surface orthogonal to the axial direction is formed on the tip of the drug discharge tube 22.
  • a hole for discharging a drug is formed on the central part of the axis of the flat surface.
  • the outer shape of the flat surface i.e., the outer edge of the tip of the drug discharge tube 22, is a circle.
  • the flat surface at the tip and the side face (tapered surface) of the drug discharge tube 22 communicate with each other at the outer edge of the tip of the drug discharge tube 22.
  • the drug discharge tube 22 has a cylindrical lock mechanism 23 provided at its back end (upper side in the figure) for coaxially surrounding the drug discharge tube 22, for example.
  • the cross-section of the cylinder of the lock mechanism 23 on its inner periphery is a circle, while the cross-section thereof on its outer periphery is a hexagon by which the lock mechanism 23 is easily twisted with hands, for example.
  • the lock mechanism 23 is made of a member different from the syringe 3, and is fixed to the back end of the drug discharge tube 22 by bonding or fitting, or with a screw.
  • the lock mechanism 23 has a screw portion 24 on an inner wall of the cylinder. This screw portion 24 is formed to be capable of being threadedly engaged with a screw portion 17 formed on a later-described fitting portion 12 of the injection needle assembly 2.
  • the screw portion 24 is a female screw formed with a double helical thread groove.
  • the syringe 3 and the lock mechanism 23 are made of synthetic resin (plastic), for example.
  • synthetic resin material include polypropylene, polycarbonate, polyethylene, and cycloolefin polymer.
  • the injection needle assembly 2 illustrated in Fig. 2 includes an injection needle 11, and a hub 13 which holds the injection needle 11 and is provided with the fitting portion 12.
  • the injection needle 11 is a metallic needle tube having a hollow needle hole in an axis direction. A blade surface that is to puncture a skin is formed on the tip of the injection needle 11.
  • Known ones can be used as the injection needle 11.
  • a stainless steel needle with a size of 33 to 26 G (outer diameter of 0.2 to 0.45 mm) specified in the standard (ISO 9626: 1991/Amd. 1:2001 (E)) for medical needle tubes in ISO can be used for the injection needle 11.
  • ISO ISO 9626: 1991/Amd. 1:2001 (E)
  • the hub 13 includes a first member 14, a second member 15, and an elastic member 16.
  • the first member 14 is entirely formed into almost a cylindrical shape.
  • the first member 14 has the fitting portion 12, to which the drug discharge tube 22 is fitted, at one end (upper side in the figure), an intermediate portion 31, into which the elastic member 16 is inserted, at the hollow central part, an insertion portion 32, into which the second member 15 is inserted, on the other end, and a flange-type fixing portion 33 at an outer periphery of the other end for bonding and fixing the second member 15.
  • Fig. 3 illustrates an enlarged sectional view illustrating the fitting portion 12 of the first member 14.
  • the fitting portion 12 is formed into a cylinder, and an opening end at its one end is specified as a fitting opening 12a to which the drug discharge tube 22 is fitted.
  • the fitting portion 12 has a fitted wall 12c, which is fitted to the drug discharge tube 22, on the inner wall of a cylinder hole 12b.
  • the fitting portion 12 preferably has a guide wall 12d on the inner wall of the cylinder hole 12b at the side of the fitting opening 12a.
  • the fitted wall 12c is formed into a female taper shape in which the inner diameter of the cylinder hole 12b continuously decreases toward the inner side from the fitting opening 12a.
  • This taper shape is formed with a taper ratio of M/100 under the condition of M > N.
  • the fitted wall 12c is formed such that the inner diameter of the cylinder hole 12b can be fitted to the drug discharge tube 22 of the syringe 3.
  • the cylinder hole 12b at the fitted wall 12c is formed to satisfy the relationship of Dmax > K > Dmin, when the diameter of the tip of the drug discharge tube 22 is defined as K (see Fig. 2 ), the diameter (maximum diameter) of the fitted wall 12c at the side of the fitting opening 12a is defined as Dmax, and the diameter (smallest diameter) at the inner side is defined as Dmin.
  • the drug discharge tube 22 is fitted such that the tip thereof is located at the position slightly inner from the position where the diameter of the cylinder hole 12b becomes K.
  • the guide wall 12d is formed by increasing the inner diameter of the cylinder hole 12b at the side of the fitting opening 12a. It is more preferable to form the guide wall 12d by increasing the inner diameter of the cylinder hole 12b at the side of the fitting opening 12a than that of the entire cylinder hole 12b formed from the fitted wall 12c having the taper ratio of M/100.
  • the guide wall 12d is preferably formed to have a taper shape in which the inner diameter of the cylinder hole 12b decreases from the fitting opening 12a to the inner side.
  • the length of the guide wall 12d in the axis direction is about 0.5 L to 2 L, for example.
  • the guide wall 12d and the fitted wall 12c are smoothly connected to each other so as not to form a step between the guide wall 12d and the fitted wall 12c with a tapered connection wall 12e in which the diameter at the inner side decreases as illustrated in Fig. 3 , or with a connection wall using curved lines.
  • the angle X between the connection wall 12e and the fitted wall 12c is preferably formed to be an obtuse angle (90° ⁇ X ⁇ 180°), more preferably formed to be 120° ⁇ X ⁇ 180°.
  • the fitting portion 12 has the screw portion 17, which can be threadedly engaged with the screw portion 24 of the lock mechanism 23 provided to the drug discharge tube 22, on the cylindrical outer periphery, for example.
  • the screw portion 17 is a male screw formed with a double helical screw thread.
  • the screw portions 17 and 24 may be a single helical screw.
  • the second member 15 illustrated in Fig. 2 includes a columnar base portion 41 that is just inserted into the insertion portion 32 of the first member 14, a columnar adjustment portion 42 that is coaxial with the base portion 41 and projects to the needle tip, a guide portion 43 formed into a flange shape at an outer periphery of the other end of the base portion 41, and a cylindrical stabilization portion 44 projecting toward the other end of the guide portion 43 so as to surround the adjustment portion 42.
  • the base portion 41 and the adjustment portion 42 are provided with a through-hole penetrating the axis for fixing the injection needle 11.
  • the base portion 41 is provided with a transverse hole 45 penetrating through a side wall at the center of the side wall.
  • the transverse hole 45 is formed for fixing the injection needle 11 with an adhesive agent inserted into the transverse hole 45.
  • the tip end surface of the adjustment portion 42 contacts a skin, whereby the adjustment portion 42 regulates the depth of the injection needle 11 punctured into the skin.
  • the guide portion 43 is provided for bonding and fixing the fixing portion 33 of the first member 14.
  • the stabilization portion 44 is provided to protect the injection needle 11 in use.
  • a cap (not illustrated) for covering the tip of the injection needle 11 is mounted to the guide portion 43 or the stabilization portion 44 when the injection needle assembly 2 is not used.
  • the first member 14 and the second member 15 are made of synthetic resin with casting.
  • the synthetic resin material include polypropylene, polycarbonate, polyethylene, and cycloolefin polymer.
  • the first member 14 is made of a material with hardness equal to the hardness of the material of the drug solution discharge tube 22, or made of a material softer than the drug solution discharge tube 22.
  • the distal end of the injection needle 11 penetrates the elastic member 16 in a liquid-tight manner.
  • the elastic member 16 is provided to prevent leakage of a drug toward the needle tip.
  • the injection needle assembly 2 is manufactured as described below. Firstly, the injection needle 11 is inserted into the through-hole of the base portion 41 of the second member 15. The needle tip of the injection needle 11 is set to project from the adjustment portion 42 by a prescribed length to be punctured into a skin, and with this state, an adhesive agent is inserted from the transverse hole 45 formed on the base portion 41 to bond and fix the second member 15 and the injection needle 11. The adhesive agent is not illustrated in each figure. Then, the elastic member 16 is inserted into the intermediate portion 31 of the first member 14. Subsequently, an adhesive agent is applied to the guide portion 43 of the second member 15, and then, the base portion 41 of the second member 15 is inserted into the insertion portion 32 of the first member 14. Then, the fixing portion 33 of the first member 14 and the guide portion 43 of the second member 15 are bonded and fixed to each other. Thus, the injection needle assembly 2 is completed.
  • Figs. 4 to 7 illustrate the state in which the drug injection device 1 is assembled by fitting the injection needle assembly 2 and the drug discharge tube 22 of the syringe 3 to each other.
  • the tip of the drug discharge tube 22 is inserted into the cylinder hole 12b from the fitting opening 12a of the fitting portion 12.
  • the tip of the drug discharge tube 22 is easily inserted into the fitting opening 12a, because the inner diameter of the guide wall 12d is formed to be large.
  • the drug discharge tube 22 is further inserted into the cylinder hole 12b.
  • the tip of the drug discharge tube 22 is not damaged because the connection wall 12e is obliquely formed in the tapered shape.
  • the injection needle assembly 2 and the lock mechanism 23 are relatively rotated to allow the screw portions 17 and 24 to be threadedly engaged with each other .
  • the drug discharge tube 22 is deeply inserted into the cylinder hole 12b with tightening of the lock mechanism 23.
  • the drug discharge tube 22 is brought into contact with the fitted wall 12c of the fitting portion 12 with this insertion.
  • the taper ratio of the fitted wall 12c is larger than the taper ratio of the drug discharge tube 22. Therefore, only the outer edge of the tip of the drug discharge tube 22 is in contact with the fitted wall 12c.
  • the drug discharge tube 22 is still further inserted while the outer edge of the tip of the drug discharge tube 22 is pressed against the fitted wall 12c.
  • the fitted wall 12cmade of synthetic resin is deformed to be hollowed, so that the outer edge of the tip of the drug discharge tube 22 bites into the fitted wall 12c.
  • the attachment of the injection needle assembly 2 to the drug discharge tube 22 is completed in the state in Fig. 7 , and thus, the drug injection device 1 is completed. With this state, the tip end surface of the drug discharge tube 22 and the elastic member 16 are in close contact with each other.
  • the outer edge of the tip of the drug discharge tube 22 is a narrow circular region. All pressure for pressing the drug discharge tube 22 against the fitted wall 12c is concentrated on this narrow region. Therefore, even if the force for pressing the drug discharge tube 22 against the injection needle assembly 2 is weak, the outer edge of the tip of the drug discharge tube 22 easily bites into the fitted wall 12c, because the fitted wall 12c is easily deformed. Accordingly, the injection needle assembly 2 and the drug discharge tube 22 are firmly fitted to each other in a liquid-tight manner, whereby a liquid leakage can surely be prevented.
  • the injection needle assembly and the drug discharge tube have a taper shape with the same taper ratio. Therefore, it is necessary to apply pressure to cause both surfaces to rub against each other, and hence, friction resistance becomes large and relatively large force is required. However, by applying the present invention, the injection needle assembly and the drug discharge tube can surely be fitted to each other even with weak force.
  • the material of the first member 14 is not limited to a relatively soft material such as polypropylene.
  • a relatively hard material such as polycarbonate or cycloolefin polymer can also be used, because the drug solution discharge tube 22 sufficiently bites due to pressure concentrated on the outer edge of the tip of the drug solution discharge tube 22.
  • the lock mechanism 23 of the syringe 3 has a cylindrical shape surrounding the fitting portion 12 as illustrated in Fig. 7 , the lock mechanism 23 can prevent the increase in the diameter of the cylinder hole 12b due to the deformation of the cylinder hole 12b caused by the pressure upon fitting the drug discharge tube 22. Accordingly, the drug discharge tube 22 and the fitted wall 12c can more surely be fitted to each other. It is preferable that the screw portion 17 is formed on the outer periphery close to the fitting opening 12a of the fitting portion 12 in order that the lock mechanism 23 surrounds the portion near the fitting opening 12a of the fitting portion 12 having a small thickness.
  • Fig. 8 illustrates an embodiment having another lock mechanism
  • Fig. 9 illustrates an embodiment having no lock mechanism.
  • a syringe 3a illustrated in Fig. 8 has a screw portion 24a serving as a lock mechanism at the back end on the outer periphery of a drug discharge tube 22, and an injection needle assembly 2a has a screw portion 17a on the inner wall of a cylinder hole 12b of a fitting portion 12.
  • the screw portion 24a is a male screw
  • the screw portion 17a is a female screw.
  • the screw portions 17a and 24a are threadedly engaged with each other in the cylinder hole 12b of the fitting portion 12.
  • the lock mechanism (screw portion) mounted to the drug discharge tube and the screw portion formed on the injection needle assembly are not limited to the above examples. It is only necessary that a male screw or a female screw corresponding to a lock mechanism is formed on a drug discharge tube, and a female screw or a male screw corresponding to the lock mechanism is formed on a fitting portion.
  • a drug discharge tube 22 of a syringe 3b illustrated in Fig. 9 does not have a lock mechanism 23, and an injection needle assembly 2b does not have a screw portion 17 on a fitting portion 12.
  • the drug discharge tube 22 and the injection needle assembly 2b are fitted to each other only by the fitting of the outer edge of the tip of the drug discharge tube 22 to a fitted wall 12c of the fitting portion 12.
  • the injection needle assembly 2 and the drug injection device 1 illustrated in Figs. 1 to 7 have the strongest holding force
  • the injection needle assembly 2a and the drug injection device 1a illustrated in Fig. 8 has the second strongest holding force
  • the injection needle assembly 2b and the drug injection device 1b illustrated in Fig. 9 has the third strongest holding force.
  • Any shape may appropriately be used for a lock mechanism, and whether a lock mechanism is provided or not may also be appropriately selected, according to a gauge or injection pressure of an injection needle.
  • N 6 in the taper ratio of the drug discharge tube 22 have been described. However, N can be changed as necessary.
  • the value of M at the fitting portion 12 may be changed according to N.
  • the example in which the cylinder hole 12b of the fitting portion 12 has the guide wall 12d has been described. However, the entire cylinder hole 12b may be formed from the fitted wall 12c without having the guide wall 12d.
  • the first member 14 and the second member 15 of the injection needle assembly 2 may be integrally formed with the same member.
  • the injection needle assembly 2 may be configured to have a long projecting needle tip without having the adjustment portion 42 or the stabilization portion 44, for example.
  • the example in which the drug discharge tube 22 is attached to the tip of the syringe 3 has been described. However, the drug discharge tube 22 may be attached to a tip of a tube through which a drug flows, for example.
  • Examples 1 to 4 illustrate manufacturing examples for experimentally producing injection needle assemblies to which the present invention is applied, and Comparative Examples 1 and 2 illustrate manufacturing examples for experimentally producing injection needle assemblies to which the present invention is not applied.
  • injection needle assemblies illustrated in Figs. 1 to 7 were prepared, each injection needle assembly having a different taper ratio of a fitted wall of a fitting portion.
  • the injection needle assembly in Comparative Example 2 was prepared such that the entire fitting portion had the taper ratio of 6/100, which was a conventional product.
  • Each of these injection needle assemblies was manufactured with a size corresponding to a drug discharge tube (diameter of a tip of a taper: 3.95 mm) with a taper ratio of 6/100.
  • cycloolefin polymer (ZEONEX (registered trademark) manufactured by Nippon Zeon Co., Ltd.) was used.
  • Table 1 illustrates the taper ratios and sizes in Examples 1 to 4 and Comparative Examples 1 and 2.
  • Table 1 Injection needle assembly Taper ratio Taper tip diameter Dmin (mm) Note Example 1 9/100 3.789 Example 2 12/100 3.723 Example 3 15/100 3.657 Example 4 18/100 3.591 Comparative Example 1 6/100 3.526 Comparative Example 2 6/100 4.260 Conventional product
  • a syringe having a drug discharge tube with a taper shape of 6/100 was prepared.
  • the material of the syringe was cycloolefin polymer (ZEONEX (registered trademark) manufactured by Nippon Zeon Co., Ltd.) .
  • the needle tip of the injection needle in each of Examples 1 to 4 and Comparative Examples 1 and 2 was sealed with a hot melt adhesive resin, and the injection needle was attached to the drug discharge tube of the syringe.
  • the syringe was filled with water colored with red, and using a load measuring device (Autograph (registered trademark) AGS-J-4 manufactured by Shimadzu Corporation), a pusher inserted into the syringe was pushed with speed of 30 mm/min, and a load when water leaks from the fitted portion (tapered shape portion) between the drug discharge tube and each of the injection needle assemblies was measured.
  • a load measuring device Autograph (registered trademark) AGS-J-4 manufactured by Shimadzu Corporation
  • Fig. 10 illustrates the test result.
  • the injection needle assemblies in Examples 1 to 4 have pressure resistance higher than the pressure resistance of the assembly in Comparative Example 2 that is a conventional product.
  • pressure resistance was equal to or larger than 3 MPa when the fitting torque is 0.1 N ⁇ m.
  • pressure resistance was equal to or larger than 4 MPa when the fitting torque was 0.1 N ⁇ m.
  • Fig. 11 illustrates the measurement result. In each example, pressure resistance increased, as the insertion distance increased.
  • the injection needle assembly and the drug injection device of the present invention are used for administrating drug solution to a patient.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (5)

  1. Injektionsnadelanordnung (2), umfassend:
    eine Injektionsnadel (11);
    einen Passungsabschnitt (12), der zu einer zylindrischen Form geformt ist und ein Ende aufweist, das als Passungsöffnung (12a) dient, wobei der Passungsabschnitt (12) eine Innenkonusform aufweist, bei der ein Innendurchmesser eines Zylinderlochs (12b) des Passungsabschnitts (12) in Richtung zur Innenseite der Passungsöffnung (12a) hin kleiner wird; und
    eine Nabe (13), die mit dem Passungsabschnitt (12) zum Halten der Injektionsnadel (11) versehen ist,
    wobei die Injektionsnadelanordnung (2) so konfiguriert ist, dass sie in einer solchen Weise verwendet wird, dass die Innenkonusform des Passungsabschnitts (12) von der Passungsöffnung (12a) aus in ein Medikamentenabgaberohr (22) eingepasst wird, das eine Außenkonusform aufweist, bei der ein Außendurchmesser eines Zylinders in Richtung zu einer Spitze hin kleiner wird, wobei
    wenn die Außenkonusform des Medikamentenabgaberohrs (22) ein Konusverhältnis von N/100 aufweist, die konische Innenkonusform des Passungsabschnitts (12) so ausgebildet ist, dass sie ein Konusverhältnis von M/100 aufweist, wobei M>N ist,
    dadurch gekennzeichnet, dass
    der Passungsabschnitt (12) innerhalb eines Bereichs von M = 1,5 N bis 10 N ausgebildet ist, und um die Beziehung Dmax > K > Dmin zu erfüllen, wenn der Durchmesser der Spitze des Medikamentenabgaberohrs (22) als K definiert ist, ist der Durchmesser des Passungsabschnitts (12) an der Seite der Passungsöffnung (12a) als Dmax definiert und der Durchmesser an der Innenseite ist als Dmin definiert.
  2. Injektionsnadelanordnung nach Anspruch 1, wobei der Passungsabschnitt derart geformt ist, dass M auf der Basis von N = 6 bestimmt wird.
  3. Injektionsnadelanordnung (2) nach Anspruch 1, wobei
    der Passungsabschnitt (12) eine Führungswand (12d) aufweist, die an einer Innenwand des Zylinderlochs (12b) an der Passungsöffnung (12a) durch Vergrößerung des Innendurchmessers des Zylinderlochs (12b) ausgebildet ist.
  4. Injektionsnadelanordnung (2) nach Anspruch 1, wobei
    das Medikamentenabgaberohr (22) einen Verriegelungsmechanismus (23) aufweist, der mit einem Schraubabschnitt (24) versehen ist, und
    der Passungsabschnitt (12) einen Schraubabschnitt (17) aufweist, der mit dem Schraubabschnitt (24) des Verriegelungsmechanismus (23) in Gewindeeingriff steht.
  5. Medikamenteninjektionsvorrichtung (1), umfassend:
    eine Spritze (3), die das Medikamentenabgaberohr (22) aufweist; und
    die Injektionsnadelanordnung (2) nach Anspruch 1.
EP13881154.2A 2013-04-05 2013-04-05 Injektionsnadelanordnung und medikamenteninjektionsvorrichtung Active EP2982402B1 (de)

Applications Claiming Priority (1)

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PCT/JP2013/060429 WO2014162583A1 (ja) 2013-04-05 2013-04-05 注射針組立体及び薬剤注射装置

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EP2982402A1 EP2982402A1 (de) 2016-02-10
EP2982402A4 EP2982402A4 (de) 2016-12-14
EP2982402B1 true EP2982402B1 (de) 2020-09-02

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WO2016043074A1 (ja) * 2014-09-19 2016-03-24 テルモ株式会社 検査システム、検査方法及び医療器具
WO2016117164A1 (ja) * 2015-01-20 2016-07-28 テルモ株式会社 注射針組立体及びそれを備えた皮膚上層部への薬液注入用注射器
JP6716542B2 (ja) * 2015-03-27 2020-07-01 テルモ株式会社 注射針組立体および薬剤注射装置
WO2016158141A1 (ja) * 2015-03-27 2016-10-06 テルモ株式会社 注射針組立体および薬剤注射装置
CN109938716B (zh) * 2019-03-27 2021-10-01 浙江糖链科技有限公司 一种血糖血压一体机及其操作方法
CN110604852A (zh) * 2019-08-20 2019-12-24 贝普医疗科技有限公司 一种可视刻度的安全式多头式注射针
CN110384844A (zh) * 2019-08-20 2019-10-29 贝普医疗科技有限公司 一种多头式注射针
CN110384845A (zh) * 2019-08-20 2019-10-29 贝普医疗科技有限公司 一种安全式多头式注射针
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US9913948B2 (en) 2018-03-13
CN105120933A (zh) 2015-12-02
CN105120933B (zh) 2019-02-19
EP2982402A4 (de) 2016-12-14
US20160022924A1 (en) 2016-01-28
EP2982402A1 (de) 2016-02-10
JPWO2014162583A1 (ja) 2017-02-16
WO2014162583A1 (ja) 2014-10-09
JP6088640B2 (ja) 2017-03-01

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